Kornimate/medical-research-clean huggingface dataset:
adapting and implementing a nurse care management model to care for rural patients with chronic pain

Conditions: Chronic Pain

Summary: chronic pain affects over 20% u.s. adults and has debilitating effects on quality of life and physical and mental health. individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain. the 46 million americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. as such, a critical need exists to implement effective, comprehensive programs for pain management that include treatment options other than medications. nurse care management (ncm) has been successfully used to enhance care for individuals with other long-term health issues. the study teams proposes to adapt, pilot, and implement a ncm model that includes care coordination, cognitive behavioral therapy (cbt), and referrals to a remotely delivered exercise program for rural patients with chronic pain.

care managers will provide care coordination to help patients address their health holistically and help link them key resources in the community. in addition, the care managers will be trained to deliver cognitive behavioral therapy (cbt) to address unhelpful thought patterns and behaviors around chronic pain and also facilitate patients' participation in enhancefitness (tele-ef), an evidence-based exercise program that can be accessed from home. the rationale is that both tele-ef and cbt have been independently shown to improve pain, functioning, and quality of life and that care managers could support patients in accessing and engaging in these services. this phase allows the study team to prepare for a randomized controlled trial to test the adapted ncm model with rural patients who have chronic pain. investigators plan to test the intervention in rural serving health care systems using two practice-based research networks with substantial rural presence, the wwami (washington, wyoming, alaska, montana, and idaho) region practice and research network and mecklenburg area partnership for primary care research in north carolina. in combination, recruitment in these two networks will allow the study team to reach ethnically diverse participants across broad rural geographies.

Eligibility criteria:
inclusion criteria: * current primary care patient with one care visit in the last year * experience pain for at least 3 months * live in a rural area * proficient in english * a mean score ≥ 4 on the pain, enjoyment, and general activities scale exclusion criteria: * pain is cancer-related * has plans for major surgery in the next 6 months * has received skills training or education for pain management in the past 6 months * moderate or severe cognitive impairment (documented diagnosis or score 12 or lower on the telephone montreal cognitive assessment) * living in a nursing home or inpatient treatment facility

Keywords: chronic pain behavioral health rural health telehealth exercise
multi-center adolescent clavicle fracture trial: operative vs. non-operative treatment

Conditions: Clavicle Fracture

Summary: investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. among the primary goals of research projects stemming from the first arm of this registry, facts a, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. the second arm of the registry, facts b, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.


Eligibility criteria:
inclusion criteria: * aged 10-18 * diagnosis of a primary diaphyseal clavicle fracture * fracture must be completely displaced * patient - bch subjects must pursue follow-up at bch main campus or waltham must be 59 days or less from the primary fracture * all study patients (across all sites) must agree to be contacted by a long-term follow-up coordinator based out of boston children's hospital for long-term follow-up questions (out to the 2-year time point). this can/will be done via phone, mail, text message, and/or email. exclusion criteria: * pathological fracture * previous ipsilateral fracture * unable to fill out outcome collection forms * refusal to participate * underlying neurologic or neurocognitive disorder that affects ue function * underlying metabolic bone disorder (e.g. osteogenesis imperfecta) that significantly alters normal bone healing * unable to project injury x-ray films if treated initially at an institution that is not a member of this register

Keywords: adolescent
glaucoma eye drop instillation: impact of education

Conditions: Glaucoma, Open-Angle

Summary: the purpose of this study is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. the investigators predict that the educational intervention will have a positive impact on the efficacy, safety, and efficiency with which patients administer their eye drops.

glaucoma is a leading cause of irreversible vision loss worldwide, and as such has a large public health impact. the only treatment proven to slow or arrest the progression of the disease process is intraocular pressure (iop) reduction, which relies heavily on patient cooperation. previously, nonadherence to glaucoma medications has ranged from 24% to 59%. barriers to medication compliance in the glaucoma patient population include health literacy, poor comprehension of disease, poor comprehension of medication regimen, and improper eye drop administration technique. the purpose of this randomized, controlled clinical trial is to assess whether an educational intervention will have a positive effect on patients' ability to properly administer eye drops. patients randomized to the experimental group will receive the educational intervention, consisting of an instructional video demonstrating how to instill eyedrops. patients randomized to the control group will receive an attention placebo, consisting of a video regarding healthy eating tips. additional measures that will be obtained from all patients include a health literacy score, as measured using the realm questionnaire, and a bmq - specific score (beliefs about medicines questionnaire) using the bmq-specific questionnaire. if the education protocol is found to positively affect eye drop administration success, as demonstrated by a statistically significant difference between the experimental and control groups, suggestions will be proposed for the implementation of educational programs similar to ours to improve glaucoma patient outcomes.

Eligibility criteria:
inclusion criteria: * established care with the treating ophthalmologist for at least 6 months * diagnosis of open-angle glaucoma or ocular hypertension * the use of one, two or three self-instilled eye drop medications in one or two eyes * age 40-85 years * fluency in english * best corrected visual acuity (bcva) of 20/50 or better in each eye exclusion criteria: * presence of moderate to severe cognitive deficits * presence of a clinically significant tremor * mini mental status exam score ≤ 20

Keywords: glaucoma, open-angle ophthalmic solutions, eye drops instructional films and videos
reaching clinical recommendations for intensity of post-stroke rehabilitation

Conditions: Stroke

Summary: the project aims to implement workstations for mobility training during intensive inpatient rehabilitation to increase the level of motor activity of individuals with hemiparesis due to stroke


Eligibility criteria:
inclusion criteria: * receving intensive rehabilitation care for hemiparesis due to stroke in our rehabilitation facility (irglm) exclusion criteria: * cognitive deficits preventing participation to rehabilitation
surface hardness and wear characteristics of prefabricated and cad/cam milled artificial teeth

Conditions: Surface Hardness and Wear Resistance of Artificial Teeth

Summary: purpose: this study aimed to assess the 3-dimentional wear )3d) (volumetric loss) and 2-dimentional wear (2d) (vertical loss) and surface hardness of ready-made (prefabricated) and cad/cam milled artificial denture teeth. material and methods: in a cross-over study design, ten completely edentulous patients were randomly chosen for this study and given two complete dentures. the first complete denture was constructed with pre-fabricated teeth. the second complete denture was constructed with cad\\cam milled teeth. the complete denture teeth were 3d scanned at the time of insertion (t0), after three months (t3), and after six months (t6) of denture insertion. utilizing 3d surface superimposition techniques, the vertical (2d wear), and volumatic (3d wear) material loss were measured. the hardness of the teeth were evaluated at the time of denture insertion (t0) then after 6 months (t6) of denture insertion by vickers hardness test. statistical analysis was done using spss software. paired groups were compared by paired t test. significant difference was considered if p ≤ 0.05.


Eligibility criteria:
inclusion criteria: * completely edentulous * angle class i maxillomandibular relations exclusion criteria: * angle's class ii, iii maxillomandibular relation * systemic disease that affect the bone and soft tissue health
effects of music combined with sports games on alleviating psychological stress, anxiety and mental energy among adolescents during covid-19 pandemic in lanzhou gansu province china

Conditions: Stress; Anxiety and Fear

Summary: the objective of this observational study was to assess whether music and sports play interventions were effective in reducing stress, anxiety and fear of covid-19 among secondary school students in gansu province; the effects of music, sports games, and music combined with sports games were compared.


Eligibility criteria:
inclusion criteria: * 1. secondary schools' students (both maile and female) in lanzhou city, years (14-17 years old). * 2. able to read and understand the chinese version questionnaires. * 3. understand the information explained by the researcher and agree to be included in the study. * 4. they are in good health, measured by par-q * 5. participants who written consent to participate in the study. exclusion criteria: * participants with disabilities that prevent them from physically active. also, those who withdraw in the middle or at the end of the intervention before answering the questionnaire of post-trial.

Keywords: stress, anxiety and fear of covid-19
sorbent therapy of the cutaneous porphyrias

Conditions: Erythropoietic Protoporphyria

Summary: the investigators demonstrated that cholestyramine is an effective binding agent in vitro for porphyrins. a few isolated case reports of treatment of individuals with a cutaneous porphyria suggest that cholestyramine and colestipol effectively remove porphyrins. hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (epp).

four adults with proven epp volunteered as subjects for this study. first period: subjects received 1 gm colestipol twice daily for \~45 days, then 2 gm twice daily for \~45 days. labs included cbc; liver chemistries including cholesterol; serum iron, tibc and ferritin; erythrocyte and plasma protoporphyrin concentrations; and completion of sun exposure questionnaire focused on cutaneous manifestations every 2-4 weeks. second period: subjects received colestipol tablets, 2 grams twice daily, completing the sun exposure questionnaire and protoporphyrin determinations \~monthly for 5-6 months.

Eligibility criteria:
inclusion criteria: * adult over age 21 * healthy exclusion criteria: * intercurrent illness * pregnancy

Keywords: sorbent resin epp cutaneous porphyria adult over age 21 without intercurrent illness not pregnant willing to participate
bioequivalence study for an isotretinoin

Conditions: Skin Infections (Acne)

Summary: the objective of this study was to confirm if two formulations of isotretionin (capsules) are bioequivalent. test product was oratane® 20 mg (laboratorios dermatológicos darier) and reference product roaccutan® 20 mg (productos roche). two capsules administered together were the single dosage. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fed conditions. the population was composed of 36 healthy volunteers, male adults between 18-45 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: male volunteers. ages between 18 and 45 years old. bmi (body mass index) between 20 to 26 kg/m2. anti-doping tests negative results. clinical biochemical test values: hematic biometry, urine analysis, biochemical profile: (glucose, ureic nitrogen, urea, creatinine, uric acid, cholesterol, triglycerides, total proteins, albumin, globulin, bilirubin (total, indirect and direct), alkaline phosphatase, lactic dehydrogenase, ast, alt, calcium, phosphorus, sodium, potassium, chlorine and iron), ac vih, agshb and rpr (luetic test), must fall within an interval between minimum and maximum values in connection to said tests accepted values. normal electrocardiogram and chest x-rays. in exception cases, accepted may be a candidate for which any previously mentioned test is exceeded regarding considered valid maximum and minimum accepted normal values, as long as it involves an isolated value and there are no other manifestations which could allow assuming that a given value is related to a disease or is remnant of another. these cases must be approved by clinical area and declared as "non-clinically significant". - exclusion criteria: electrocardiographic anomalies; radiological anti-doping tests positive results, positive results regarding rpr; vih and agshb tests. personal or family history of allergy to medication in question. having any kind of allergy, since these persons are in higher risk of suffering from medicamentous allergy. tobacco use. recreational drug use. persons undergoing any medical treatment. existence of concurrent or intercurrent disease. existence of justified doubt regarding questionnaire answers truthfulness. having participated in bioequivalence or bioavailability studies or having donated blood 2 months before the study. presence of clinically important gastrointestinal diseases or malabsorption history during the last year. presence of a medical condition requiring regular medication (with prescription or over-the- counter medication) with systemic absorption. narcotics or alcohol addiction history requiring treatment. finally, excluded will be all those volunteers not meeting that established in mexican official standard nom-177-ssa1-1998. -

Keywords: pharmacokinetics isotretinoin bioequivalence mexico
opioid reduced anesthesia with parasternal catheters on postoperative delirium after cardiac surgery

Conditions: Cardiac Disease

Summary: postoperative delirium (pod) is the most common neuropsychiatric complication following cardiac surgery and may be related to morphine consumption. postoperative delirium (pod) prolongs hospital and intensive care unit (icu) length of stay (los) and increases morbidity and mortality. no study has been conducted to demonstrate the effect of regional anesthesia using catheters inserted before sternotomy.

this study investigate the effect of an enhanced recovery protocol using regional anesthesia on postoperative delirium (pod) onset.

Eligibility criteria:
inclusion criteria: * age over 18 * admitte for scheduled cardiac surgery with sternotomy under cardiopulmonary bypass (cpb) for coronary artery bypass grafting (cabg), surgical correction of valve disease (aortic, mitral or tricuspid) or combined surgery (coronary artery bypass grafting (cabg) and valve replacement). exclusion criteria: * age over 85, * emergency surgery or heart transplant, * body mass index (bmi) more than 40 kg.m-2 * reoperation * renal insufficiency with glomerular filtration rate (gfr) less than 30 ml.min-1 * left ventricular ejection fraction less than 30% * respiratory insufficiency with arterial pressure of oxygen less than 60 mmhg * hepatic insufficiency with prothrombin rate less than 30% or cirrhosis * chronic hyperglycemia not controlled * pregnancy * cognitive impairment chronic use of opioids or drug addiction * epilepsy * guardianship * allergy to locals anesthesics or any drugs

Keywords: cardiac surgery postoperative delirium regional anesthesia enhanced recovery after surgery
tcr-redirected t cells therapy in patient with hbv related hcc

Conditions: Hepatocellular Carcinoma

Summary: this is a single center. single arm, open-label study to determine the safety and clinical benefit of tcr-redirected t cell therapy in patient with hbv related hcc post hepatectomy or radiofrequency ablation.


Eligibility criteria:
inclusion criteria: 1. expression of the specific human leukocyte antigen (hla) class i profile 2. hepatocellular carcinoma (hcc) with positive test for hepatitis b virus surface antigen (hbsag) 3. bclc stage c 4. at least 1 month after surgical intervention or 2 weeks after tace (may include other type of resection/ablation) no major post-operative complication 5. laboratory criteria: 1. liver function: child a, alt \< 200 u/l, ast \< 200 u/l, tbil \< 17.1umol/l 2. renal function: creatinine clearance ≥ 60ml/minute 3. cardiac function: no abnormality in cardiac enzyme and ecg 4. pulmonary function (lung): no abnormality in chest x-ray 6. sexually active subjects must be willing to use an acceptable method of contraception 7. willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures exclusion criteria: 1. subject experiencing acute infection or gastric bleeding within 30 days 2. mid to late stage cirrhosis, i.e. child-pugh score ≥ 7 3. known history of testing positive for human immunodeficiency virus (hiv) 4. other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease 5. serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy 6. women who are pregnant or breast-feeding 7. history of allergic reaction to blood products or investigational products 8. history of chronic alcoholism or drug abuse/addiction 9. require systemic medications, such as steroids during the period of study drug administration 10. exposure to any cell therapy such as, but not limited to nk, cik, dc, ctl, stem cells therapy 6 months prior to study drug administration 11. use of any investigational product (ip) or investigational medical device 12. any condition which could jeopardize the safety of the patient and his/her compliance in the study
optimising health in type 1 diabetes

Conditions: Diabetes Mellitus

Summary: type 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. when there is severe insulin deficiency, life-threatening ketoacidosis can develop. treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management. the optimise diet is a multi-pronged diet based on "best health" principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. in this study, its effects will be compared to the standard diabetes diet that is currently recommended in australia and internationally.

the rationale for this study is to determine whether a diet based on recent scientific advances in diet-induced inflammation, will improve diabetes care in people with type 1 diabetes.

Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.

Keywords: glucose inflammation
reduction of preoperative anxiety in children: clickamico project 2nd phase

Conditions: Preoperative Anxiety

Summary: the purpose of this study is to evaluate the efficacy of a video shown using an ipad, compared to a standard treatment, to reduce preoperative anxiety in children who have to undergo to elective surgery procedure


Eligibility criteria:
inclusion criteria: * age between 6 and 11 * no cerebral impairment or cognitive impairment * child and his/her family native speaker of italian * admission to the hospital at list one day before the sugery procedure * presence of written consent of the parents to the study exclusion criteria: * age lower than 6 or upper than 11 * presence of cerebral impairment or cognitive impairment * child and his/her family are not native speaker of italian * absence of written consent of the parents to the study